POLIGRIP EXTRA STRENGTH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-03-16 for POLIGRIP EXTRA STRENGTH manufactured by Gsk Dungarvgan Stafford-miller.

Event Text Entries

[5700643] This case was reported by a consumer and described the occurrence of a seizure in a (b)(6) female pt who received triple salt dental adhesive cream (poligrip extra strength) for an unk indication. Co-suspect products included double salt dental adhesive cream (super poligrip extra care with poliseal (zinc free formula)) (batch number z07082a, exp date unk) for an unk indication. On an unk date, the pt started poligrip extra strength and super poligrip extra care with poliseal (zinc free formula). On an unk date, and unk time after starting poligrip extra strength and super poligrip extra care with poliseal (zinc free formula), the pt experienced seizure (serious criteria gsk medically significant), vascular rupture and brain operation (serious criteria gsk medically significant). Poligrip extra strength and super poligrip extra care with poliseal (zinc free formula) were discontinued (dechallenge was positive). On an unk date, the outcome of the seizure, vascular rupture, and brain operation were recovered/resolved. The reporter considered the seizure and vascular rupture to be possibly related to poligrip extra strength. It is unk if the reporter considered the brain operation to be related to poligrip extra strength and super poligrip extra care with poliseal (zinc free formula). It was unk if the reporter considered the seizure and vascular rupture to be related to super poligrip extra care with poliseal (zinc free formula). This report is made by gsk without prejudice and does not imply and admission or liability for the incident or its consequences. On (b)(6) 2015, the consumer called to inquire about the use of super poligrip extra care pre and post zinc. She wanted to know if we had any reports of blood vessel bleeds causing seizures in regard to the product. She reported using the product for 12 years, some of which were when the product still contained zinc. Three years ago she quit using the product subsequent to brain surgery and never had the issues again. Her neurologist informed her that zinc could possibly be the cause of her seizures and blood vessel bleeds.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9681138-2015-00010
• MDR Report Key: 4609725
• Report Source: 04
• Date Received: 2015-03-16
• Date of Report: 2015-03-10
• Date Mfgr Received: 2015-03-10
• Date Added to Maude: 2015-03-20
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: PO BOX 13398
• Manufacturer City: RESEARCH TRIANGLE PARK NC 27709
• Manufacturer Country: US
• Manufacturer Postal: 27709
• Manufacturer Phone: 8888255249
• Manufacturer G1: GSK
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: POLIGRIP EXTRA STRENGTH
• Generic Name: DENTURE ADHESIVE
• Product Code: KOL
• Date Received: 2015-03-16
• Operator: LAY USER/PATIENT
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GSK DUNGARVGAN STAFFORD-MILLER
• Manufacturer Address: DUNGARVAN CO., WATERFORD EI

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-03-16